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Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Crossmatch Deceased Donor Kidney Transplant

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ClinicalTrials.gov Identifier: NCT01106027
Recruitment Status : Terminated (Difficulty enrolling; competing industry-funded multi-center clinical trial)
First Posted : April 19, 2010
Results First Posted : November 14, 2017
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Mark Stegall, Mayo Clinic

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Kidney Transplant
Intervention: Drug: Eculizumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from Mayo Clinic in Rochester, Minnesota.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Eculizumab

Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.

At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.


Participant Flow:   Overall Study
    Eculizumab
STARTED   2 
COMPLETED   1 
NOT COMPLETED   1 
Lost graft early, discontinued                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Eculizumab

Patients will be given 1200 mg of eculizumab intravenously over 30 minutes, 1 hour prior to surgery. Patients will be given 900 mg of eculizumab on Day 1 post-transplant. Patients will then be given 900 mg of eculizumab weekly through 4 weeks post-transplant.

At week 4, patients will be assessed for donor specific anti-donor human leukocyte antigen (HLA) antibody (DSA). Patients with total DSA normalized values <5000 will stop eculizumab treatment. Patients with total DSA normalized values >5000 will continue eculizumab treatment every 14 days from week 5 through week 9. The dose will be increased to 1200 mg and dosing will now be every 2 weeks instead of weekly.


Baseline Measures
   Eculizumab 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 2 
<=18 years      0   0.0% 
Between 18 and 65 years      2 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 2 
Female      1  50.0% 
Male      1  50.0% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   
Participants Analyzed 
[Units: Participants]
 2 
United States   2 


  Outcome Measures

1.  Primary:   Number of Subjects With Acute Humoral Rejection (AHR) up to One Year Post Transplant.   [ Time Frame: 1 year posttransplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early due to difficulty enrolling and competing industry-funded multi-center clinical trial.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark Stegall
Organization: Mayo Clinic
phone: 507-284-6275
e-mail: Stegall.Mark@mayo.edu



Responsible Party: Mark Stegall, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01106027     History of Changes
Other Study ID Numbers: 09-005627DD
First Submitted: March 29, 2010
First Posted: April 19, 2010
Results First Submitted: October 12, 2017
Results First Posted: November 14, 2017
Last Update Posted: January 31, 2018